flublokBy Mitchell Young

 MERIDEN: Sanofi, [NYSE: SYN] the $111 billion  Paris, France based pharmaceutical giant announced it will purchase Protein Sciences Corp. [PSC] for up to $750 million including an up-front payment of $650 million and another $100 million if the company reaches [unannounced] benchmarks].

Protein Sciences was recognized by Business New Haven in 2011 as a greater New Haven Healthcare Hero for Innovation.

PSC developed an innovative vaccine development technology and its non-egg based Flu vaccine, Flu-blok is the only non-egg based flu vaccine approved by the US Federal Drug Administration. The business information website Owler.com estimates revenues of $34 million and 120 employees for the private company.

Sanofi does more than $40 billion in annual revenues and is one of a handful of major pharmaceutical companies with a significant vaccines’ business, approximately $5 billion annually.

In a world of pharma giants. marketing Flu-blok has been a challenge for PSC, a relatively tiny bio-tech, but that could change under Sanofi’s control

The company claims it is the world’s leading flu vaccine company with more than $1.5 billion in flu vaccine revenues.

"The acquisition of Protein Sciences will allow us to broaden our flu portfolio with the addition of a non-egg based vaccine," said David Loew, Sanofi executive vice president and head of Sanofi Pasteur, the company's vaccines' arm.

Manon M.J. Cox, President and CEO of PSC, said, “as part of Sanofi Pasteur, we expect our Flublok influenza vaccine to benefit from Sanofi Pasteur’s expertise in the field of influenza vaccines.”

Protein Sciences was founded in 1983 with the hopes of creating a vaccine for HIV/AIDS. The company struggled for more than a decade and short of funds recruited Daniel Adams, [current executive chairman of the board] to be its new CEO in 1995 and attract new capital to the company.

Adams had been a biotech executive at several companies and a co-founder [1976] and CEO of Biogen of Cambridge Mass. [now a $58 billion company].

Adams quickly jettisoned the HIV vaccine effort and turned the company toward what was hoped would be a somewhat easier target, a new non-egg based Flu vaccine.

Egg based vaccines take many months to grow and can take up to a year to produce supply once the appropriate viral target is identified.

And while with PSC technology a vaccine could be developed in days and scaled up in production in weeks, the industry’s respect for the technology and the company and its ability to attract capital was still proving difficult.

Things started to change with the September 11, 2001 terrorist attacks however, when Protein Sciences found itself on the front lines of the war against bioterrorism.

In an interview with Business New Haven, published in October 2001, then-CEO Adams revealed that the federal Centers for Disease Control (CDC) told the company that “we were the only ones who could make a vaccine to protect people against the pandemic flu in time to make a difference.”

At the time Adams suggested to the CDC that the deadliest threat might be not from bio-terrorism, but rather a reprise of the “Spanish” flu pandemic that killed 50 million people worldwide immediately following World War I.

Two years later that fear hit home across the globe, when the World Health Organization identified SARS as a new disease in 2003.

SARS spread rapidly and infected thousands of people around the world, including people in Asia, Australia, Europe, Africa as well as the Western Hemisphere.

By 2005 fear that another flu, Avian Flu virus (H5N1), would find its way to the U.S. and promising results by Protein Sciences in treating chickens against the flu convinced the FDA to put a PSC vaccine on the fast track.

By 2007 the U.S. Department of Health & Human Services committed $8.5 billion to address concerns of a pandemic flu through expanding existing vaccine facilities and funding new technologies. However, much of that money continued to be directed to large pharmaceutical companies and much of that to traditional vaccine methods.

Development costs were sinking the company just as the technology effort was turning the corner, cost for a clinical trial was $20 million.

In 2008, Protein Sciences announced the sale of the company for $78 million as word of a major U.S. government contract surfaced.

The development would be funded and finished by the acquirer, Emergent BioSolutions of Rockville Md. Emergent provided immediate funding to shore up Protein Sciences, but the deal soon fell apart with acrimony and lawsuits a plenty.

In early 2009 H1N1 surfaced as a potential pandemic virus. Like many flu strains, H1N1 started in birds and was transferred to pigs, which is why it was initially called swine flu. With pigs as hosts the flu became more suitable for transmission to humans. Eventually more than 17,000 people worldwide would die, in part due to lack of supply of vaccines.

In 2009 PSC won a contract from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health & Human Services for up to $150 million for the development of its vaccine technology, clinical testing and eventual manufacturing of the FluBlok vaccine.

Development was able to continue and FluBlok received its initial FDA approval in 2013 at the time only for adults 18-49, subsequent approvals included adults 18 and over.

Alexion logo colorBy Mitchell Young

NEW HAVEN: Alexion [Nasdaq: ALXN] stock is battling off another a report of an investigation. The company has reported that it is under investigation by the U.S. Department of Health and Human Services’ Office of Inspector General. The HSS is looking at allegations relating to Alexion’s support of, for charities that support Medicare patients by the U.S. Attorney’s Office in Massachusetts.

“We are aware that the U.S. Department of Health and Human Services Office of Inspector General is working on this inquiry with the U.S. Attorneys’ Office and the Department of Justice,” Alexion said July 6 th in a statement.

Alexion had previously reported in January that it had been subpoenaed by the U.S. Attorney requesting documents about the company’s support for charities that give financial assistance to Medicare patients, Alexion has said it is cooperating with the investigation and that other companies were also included in the probe.


By: Ana Radelat ctmirror.com

Washington> Stamford-based Purdue Pharma, the maker of pain-killer OxyContin, is the target of an increasing number of states, counties and cities suing the pharmaceutical firm, alleging it is partly to blame for the nation’s opioid epidemic.

The lawsuits are all different and some include other pharmaceutical companies and pharmacies as defendants. But Purdue is nearly always a main defendant.

The latest suit, filed last week by the state of Oklahoma, said Purdue and three other drug companies and their subsidiaries sought to increase their opioid sales by persuading doctors to expand the market beyond “a niche for cancer patients, the terminally ill and acute short-term pain” and to “prescribe opioids to a broader range of patients with chronic non-cancer-related pain.”

New Haven: Three executives from pharma giant Bristol Myers Squibb [NYSE: BMY] are finding new homes at two affiliated New Haven biotech companies. Biohaven [NYSE: BHVN] which went public two months ago with a $168 million IPO has hired two former BMY execs for key leadership positions as the company continues to move forward on developing its diverse portfolio of drugs.

Manion: new CEO at KLEO
Stock:  appointed head of Portfolio Strategy and Development at Biohaven
McGrath: Chief of Corporate Strategy and Business Development, Biohaven.

Elyse Stock, M.D. has been appointed as the company's Chief of Portfolio Strategy and Development, and St. John (Donnie) McGrath, M.D. has been appointed as Chief of Corporate Strategy and Business Development.

Douglas Manion, M.D., FRCP(C), as the new CEO of Kleo Pharmaceuticals. Manion has most recently served as SVP head of specialty development at BMS. Kleo's lead investor is Biohaven.

David Spiegel, M.D., Ph.D. co-founder of Kleo who’s technology is based on the work of his lab at Yale University, was himself appointed CEO this past September soon after the  investment led by Biohaven.

Stock was most Vice-President Global Development Leader at Bristol-Myers Squibb (BMS), where she worked for the last 19 years in various positions “developing numerous investigational agents across multiple therapeutic areas including neuroscience, oncology, immunology and cardiovascular disease.”

McGrath, served as Vice President of Business Development and Head of Search & Evaluation. was responsible for overseeing BMS' venture capital investment portfolio and provided leadership for all global external partnering activities.

iteriumOld Saybrook: Iterum Therapeutics US Limited, of Dublin Ireland is expanding its space and commitment in Old Saybrook. The company has leased  9413 square feet, at 20 Research Parkway.  The company currently occupies only 2300 square feet in building, the US director is Corey Fishman.

Iterum is a clinical stage biotech business with offices in Chicago, Dublin, Ireland, and Old Saybrook, they recently raised $65 million in a Series B Financing to support a phase 3 clinical trial for a new anti-biotic to treat urinary tract infections.

The financing was led by new investor Arix Bioscience plc, and included Pivotal bioVenture Partners, Advent Life Sciences, Domain Associates and Bay City Capital. Acording to the company alll of its current investors (Frazier Healthcare Partners, Canaan Partners, Sofinnova Ventures and New Leaf Venture Partners) also participated in the round.

The owner of the complex is Mill Meadow Development, LLC. Kevin Geenty SIOR was the sole agent in this transaction. 

Screen Shot 2017 06 21 at 12.59.31 PMBy Mitchell Young

Shares of Alexion stock have taken off after being pummeled by concerns about executive turnover at the company and reports of “aggressive sales practices." The C-Suite changes were initiated by new CEO Ludwig Hantson.

The stock was trading at $96.95 as recently as May 26, down from a 52 week high of $145.

On June 14, after the announcement, filling the last of the company’s major management slots, with the hiring of Paul Clancy the day before, as the new CFO. [Clancy was previously with Biogen of Cambridge, MA, see New CFO and A Possible Looming Write Off - Help Boost Alexion Stock ] the stock made a 9% plus gain.

On June 14, Hantson purchased $1.16 million of the stock in the open market at approximately $116 per share. He was joined by Alexion board members Christopher Couglin who picked up $230,000 of shares and Alvin Parven who purchased $100,000 worth, both at around $116 per share as well.

melinta therapeutics large

By Mitchell Young

New Haven: The FDA has approved Melinta Therapeutics' Baxdela (delafloxacin), a fluoroquinolone antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The company was founded by three of Yale University's leading scientist-researchers in 2000 as RIBx. The company first began work on the drug when it licensed it in 2006 under the then CEO Susan Froshauer, now CEO of Connecticut United for Resource Excellence [CURE]. 

The FDA also provided Qualified Infectious Disease Product (QIDP)Status which provides for an additional five-year period of market exclusivity for the approved purpose.